SOUTH SAN FRANCISCO, Calif., May 25 /PRNewswire-FirstCall/ -- Exelixis, Inc. has been notified by participating clinical investigators that abstracts containing data from the company’s Phase I clinical trials of XL647, XL880 and XL999 have been accepted at the 2006 American Society of Clinical Oncology Annual Meeting (ASCO), which is being held June 2 to 6 in Atlanta, Georgia. Data from the Phase I trials of XL647 and XL880 will be presented and discussed in the Developmental Therapeutics: Molecular Therapeutics session at 12:00 p.m. ET on Saturday, June 3rd and data from the weekly dosing arm of the Phase I XL999 trial will be published in abstract form. The accepted abstracts are:
-- A Phase I Dose-Escalation and Pharmacokinetic (PK) Study of a Novel Spectrum Selective Kinase Inhibitor, XL647, in Patients with Advanced Solid Malignancies (ASM) (Abstract # 3044)
-- A Phase I Study of a Novel Spectrum Selective Kinase Inhibitor (SSKI), XL880, Administered Orally in Patients (pts) with Advanced Solid Tumors (STs) (Abstract # 3041)
-- A Phase I Study Examining Weekly Dosing and Pharmacokinetics (PK) of a Novel Spectrum Selective Kinase Inhibitor, XL999, in Patients (pts) with Advanced Solid Malignancies (ASM) (Abstract # 13024)
“Data from these Phase I trials have provided the solid foundation on which to build our Phase II clinical programs for XL647, XL880 and XL999,” said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. “Six Phase II trials of XL999 are ongoing and the Phase II clinical trial programs for XL647 and XL880 are expected to initiate this summer.”
About XL647
XL647 is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) implicated in driving tumor cell proliferation and tumor vascularization (blood vessel formation). XL647 inhibits the EGF, HER2 and VEGF RTKs, each of which is a target of currently approved cancer therapies. In addition, XL647 inhibits EphB4, an RTK that is highly expressed in many human tumors and plays a role in promoting angiogenesis. In a broad array of preclinical tumor models including breast, lung, colon and prostate cancer, XL647 demonstrated potent inhibition of tumor growth and caused tumor regression. In cell culture models, XL647 retains significant potency against mutant EGFRs that are resistant to current small molecule EGFR inhibitors.
About XL880
XL880 is an orally available small molecule compound designed to target multiple RTKs implicated in the development, progression and spread of multiple cancers. The primary targets of XL880 are the hepatocyte growth factor (ligand for Met) and vascular endothelial growth factor RTK families, although platelet-derived growth factor receptor (PDGFR), c-KIT, FLT3 and Tie-2 are also inhibited. Activation or overexpression of Met has been documented as a negative prognostic indicator in patients with various carcinomas, and in patients with multiple myeloma, and glioma and other solid tumors. Activation of Met by mutation is the causative factor in an inherited kidney cancer syndrome, hereditary papillary renal cell carcinoma. Mutational activation of Met has also been found in sporadic papillary kidney cancer, lung carcinomas and head and neck carcinomas. Met is a key driver of tumor cell growth, motility, invasion, metastasis and angiogenesis. XL880 is the first orally bioavailable small molecule Met inhibitor to enter the clinic.
About XL999
XL999 is a potent inhibitor of key RTKs implicated in the development and maintenance of tumor vasculature and in the proliferation of some tumor cells. It inhibits receptors for FGF, VEGF and PDGF and exhibits excellent activity in target-specific cellular functional assays. In addition, XL999 is a potent inhibitor of FLT3, an important driver of leukemia cell proliferation in some patients with acute myelogenous leukemia (AML). In several preclinical models of human tumors, including breast, lung, colon and prostate cancer, XL999 demonstrated potent inhibition of tumor growth, and also caused regression of large well-established tumors. XL999 currently is being evaluated in Phase II trials in the following disease settings: colon, ovarian, and non-small cell lung cancers, renal cell carcinoma, AML and multiple myeloma.
About Exelixis
Exelixis, Inc. is a biotechnology company dedicated to the discovery and development of novel therapeutics that will potentially enhance the care and lives of patients with cancer and other serious diseases. The company is leveraging its fully integrated gene-to-drug platform to fuel the growth of its proprietary drug pipeline. Exelixis’ development pipeline covers cancer and metabolism and is comprised of the following compounds: XL119 (becatecarin), for which a multinational Phase III clinical trial in bile duct tumor is ongoing and which has been exclusively licensed to Helsinn Healthcare S.A.; XL784, which is being advanced in a Phase II trial as a treatment for renal disease; XL999, an anticancer compound currently in Phase II clinical trials for a variety of solid tumors; XL647, XL880, XL820, XL844 and XL184, anticancer compounds currently in Phase I clinical trials; and multiple compounds in preclinical development for diseases including cancer and various metabolic and cardiovascular disorders. Exelixis has established broad corporate alliances with major pharmaceutical and biotechnology companies including GlaxoSmithKline (GSK) and Bristol-Myers Squibb Company. Pursuant to a product development and commercialization agreement between Exelixis and GSK, GSK has the option, after completion of clinical proof-of-concept by Exelixis, to elect to develop a certain number of compounds in Exelixis’ product pipeline, which may include XL784 and the cancer compounds identified in this press release (other than XL119), thus potentially triggering milestone payments and royalties from GSK and co-promotion rights by Exelixis. For more information, please visit the company’s web site at www.exelixis.com.
This press release contains forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “slated,” “goal” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Exelixis’ current expectations. Forward-looking statements involve risks and uncertainties. Exelixis’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the potential failure of product candidates to demonstrate safety and efficacy in clinical testing; the ability of Helsinn Healthcare S.A. to conduct the Phase III clinical trial of XL119 sufficient to achieve FDA approval; the ability to complete and initiate trials at the referenced times; the ability to conduct clinical trials sufficient to achieve a positive completion; the ability to file INDs at the referenced times; the ability of Exelixis to advance additional preclinical compounds into clinical development; the uncertainty of the FDA approval process; and the therapeutic and commercial value of the company’s compounds. These and other risk factors are discussed under “Risk Factors” and elsewhere in our quarterly report on Form 10-Q for the quarter ended March 31, 2006 and other filings with the Securities and Exchange Commission. The company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Exelixis, Inc.
CONTACT: investors, Charles Butler, Director, Corporate Communications,+1-650-837-7277, or cbutler@exelixis.com, or media, Soleil MaxwellHarrison, Manager, Corporate Communications, +1-650-837-7012, orsharrison@exelixis.com, both of Exelixis, Inc.
Web site: http://www.exelixis.com//
